Snoring Intervention Via Elevoplasty in a Non-surgical Clinical Environment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-03

Study Completion Date

2017-09-29

Brief Summary

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Single Group Compared to Baseline, Non-Randomized, Multi-Center, Prospective Safety \& Efficacy Study

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RECRUITING EARLY_PHASE1

Detailed Description

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Evaluate the safety and efficacy of the Zelegent, Inc. Elevo™ Kit Snoring Intervention Device (a minimally invasive, barbed, absorbable suture implant) in the reduction of simple snoring through subjective evaluation of snoring and objective snoring sound analysis.

The Zelegent, Inc. Elevo™ Kit Snoring Intervention Device is intended to reduce or eliminate simple snoring in the target patient population via minimally invasive implantation of specialized barbed, absorbable sutures in the soft palate for the purpose of stiffening by way of shortening and lifting the soft palate thereby addressing the root cause of snoring.

Conditions

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Snoring

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single Group Compared to Baseline, Non-Randomized, Multi-Center, Prospective Safety \& Efficacy Study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Elevoplasty treatment

Single Group Compared to Baseline, Non-Randomized, Multi-Center, Prospective

Group Type OTHER

Elevoplasty

Intervention Type DEVICE

The Elevo™ Kit Snoring Intervention Device is designed to facilitate deployment of the Elevo™ suture implant into the submucosal tissue of the soft palate via a minimally invasive, outpatient procedure performed by an otolaryngologist in a medical office setting.

Interventions

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Elevoplasty

The Elevo™ Kit Snoring Intervention Device is designed to facilitate deployment of the Elevo™ suture implant into the submucosal tissue of the soft palate via a minimally invasive, outpatient procedure performed by an otolaryngologist in a medical office setting.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age \> 22 years (no maximum age)
* Has consistent Bed/Sleep Partner willing to provide Co-Participant Informed Consent
* Apnea Hypopnea Index (AHI) of \< 15 verified by polysomnogram (PSG) or by SNAP® Diagnostics Home Sleep Study (HSS)
* Has basic computer literacy (e.g., email) and home internet access or smartphone
* Chronic, simple snoring (verified by Bed/Sleep Partner)
* No prior surgical treatment for snoring
* Bed/Sleep Partner willing and capable of providing Informed Consent

Exclusion Criteria

* Age \< 22 years
* Has no consistent Bed/Sleep Partner
* Apnea Hypopnea Index (AHI) \> 15 indicative of Obstructive Sleep Apnea
* Intermittent or occasional snoring
* Body Mass Index (BMI) \> 32 kg/m2
* Modified Mallampati 3 or 4
* Tonsil Grade 3 or 4+
* Significant nasal obstruction
* Previous palatal surgery
* Current cigarette smoker
* Known history of coronary artery disease or stroke
* Chronic obstructive pulmonary disease (COPD)
* Diabetes (Type I or Type II) non-controlled by medical management
* Major depression or non-controlled psychiatric illness
* Drug or alcohol abuse
* Untreated or poorly controlled hypertension
* Anticoagulation therapy
* History of bleeding or clotting disorder
* Pregnant Female

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes